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Proof of Concept Study on BP1.4979 Effect on Essential Tremor
Sponsor: Bioprojet
Summary
The goal of this clinical trial is to learn if drug BP1.4979 works to treat essential tremors in adults. It will also learn about the safety of drug BP1.4979. The main questions it aims to answer are: * Does the drug BP1.4979 reduce tremors in individuals with essential tremor? * Do participants have a good safety and tolerability of drug BP1.4979? Researchers will compare drug BP1.4979 to a placebo (a look-alike substance that contains no drug) to see if drug BP1.4979 works to treat essential tremors. Participants will: * Take the study drug (active or a placebo) twice daily over a 4-week period * Visit the clinic 5 times for health checkups and questionnaires completion over a period of approximately 7 to 10 weeks * Complete a diary weekly to assess the impact of essential tremor on daily life
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of BP1.4979 in Adult Patients With Essential Tremor
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-09-17
Completion Date
2026-12
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
BP1.4979
Selective dopamine D3 partial agonist
Placebo
Matching placebo of BP1.4979 tablet
Locations (14)
CHU Amiens-Picardie
Amiens, France
CHU Besançon
Besançon, France
Hospices Civils De Lyon Hôpital Neurologique Pierre Wertheimer
Bron, France
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France
CHU Henri Mondor
Créteil, France
CHU de Lille - Hôpital Roger SALENGRO
Lille, France
Centre Hospitalier Régional De Marseille - Hôpital de la Timone
Marseille, France
CHRU Nancy - Hôpital Central
Nancy, France
CHU de Nice - Hôpital Pasteur 2
Nice, France
CHU de Nîmes
Nîmes, France
CHU Poitiers
Poitiers, France
CHU Rennes - CHU Pontchaillou
Rennes, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
CHU Purpan - Bâtiment Pierre Paul Riquet
Toulouse, France